Date Rape' Drug Approved for Narcolepsy

Use of Drug to Be Tightly Controlled

From the WebMD Archives

July 23, 2002 -- The FDA has approved a new use for a drug that was pulled from the market in the 1990s after it was abused and became known as the "date rape" drug.

Sold a decade ago as the dietary supplement gamma hydroxybutyrate or GHB, the drug has now been approved to treat small group of people who suffer from weak or paralyzed muscles as a result of narcolepsy.

Because of safety concerns, officials say the drug will be tightly controlled. The drug will be sold under the new name Xyrem.

Narcolepsy affects about 120,000 people in the U.S. It causes sufferers to uncontrollably fall asleep, even in the most unlikely situations, such as in the middle of a meal or conversation. In some people with narcolepsy, the condition can also cause a sudden loss of muscle control and weakness, known as cataplexy, which is usually triggered by emotions such as amusement, anger, or excitement.

Clinical trials showed Xyrem can reduce the number of these cataplectic attacks when taken at bedtime and again 2 1/2 to 4 hours after falling asleep.

In approving the drug for use, the FDA stipulated that it will be designated as a Schedule III Controlled Substance for medical use. That means it cannot be sold, distributed, or provided to anyone other than for its prescribed use. Illegal use of Xyrem will be subject to the toughest penalties allowed under Schedule I, the most restrictive schedule of the Controlled Substances Act.

During the early 1990s, GHB was marketed as a dietary supplement that purported to enhance athletic performance and sexual activity and to induce sleep. It soon became abused recreationally and became infamous for its use in date rape cases.

As a result of these adverse events, including death, the FDA has worked with the drug's manufacturer, Orphan Medical Inc., to create a highly regulated distribution and education system for the drug.

Access to the drug will be controlled through a single, centralized pharmacy. The pharmacy will send Xyrem to patients only after their doctors have provided instruction on the safe and effective use of the drug and the patients have read the information provided about the drug.

Side effects of the drug include confusion, depression, nausea, vomiting, dizziness, headache, bedwetting, and sleepwalking. Abuse of the drug could also lead to dependence and a craving for the medication with withdrawal symptoms. Doctors will be urged to see their patients who use Xyrem at least every three months for monitoring.